Stabilized nicotine chewing gum

Abstract

A nicotine chewing gum composition with improved stability.

We claim: 
     
       1. A stable chewing gum composition comprising nicotine, a chewing gum base and a flavoring agent in a liquid carrier wherein the liquid carrier for the flavoring agent is a triglyceride and the chewing gum composition contains 0% to about 0.5% by weight based upon the total weight of the chewing gum composition of a liquid containing hydroxyl moieties that promote oxidation of nicotine free base; and wherein the chewing gum composition contains no more than 6% of trans nicotine-N-oxide and no more than 4% of cis nicotine-N-oxide when placed in a sealed plastic bottle and stored for four (4) weeks at 50° C. and 75% relative humidity. 
     
     
       2. The stable chewing gum composition as defined in  claim 1  wherein the chewing gum composition is free of any liquid containing hydroxyl moieties that promote oxidation of nicotine free base. 
     
     
       3. The stable chewing gum composition as defined in  claim 1  further comprising an organoleptic additive selected from the group consisting of a plasticizer, a buffering agent, a sweetener, a filler, a coloring agent and mixtures of the foregoing. 
     
     
       4. The stable chewing gum composition as defined in  claim 1  that contains no more than 5% of the trans nicotine-N-oxide and no more than 3% of the cis nicotine-N-oxide. 
     
     
       5. The stable chewing gum composition as defined in  claim 1  that contains no more than 4% of the trans nicotine-N-oxide and no more than 2.5% of the cis nicotine-N-oxide. 
     
     
       6. The stable chewing gum composition as defined in  claim 1  that contains no more than 6% of the trans nicotine-N-oxide and no more than 3% of the cis nicotine-N-oxide when packaged in a foil backed blister package and stored for six months at 40° C. and 75% relative humidity. 
     
     
       7. The stable chewing gum composition as defined in  claim 6  that contains no more than 5% of the trans nicotine-N-oxide and no more than 2.5% of the cis nicotine-N-oxide. 
     
     
       8. The stable chewing gum composition as defined in  claim 6  that contains no more than 4% of the trans nicotine-N-oxide and no more than 2.0% of the cis nicotine-N-oxide. 
     
     
       9. A stable chewing gum composition as defined in  claim 1  wherein the chewing gum composition comprises 0% to about 0.25% by weight based upon the total weight of the chewing gum composition of a liquid containing hydroxyl moieties. 
     
     
       10. A stable chewing gum composition comprising:
 (a) Nicotine polacrilex; 
 (b) a chewing gum base; 
 (c) a flavoring agent in a hydrophobic liquid carrier wherein the hydrophobic liquid carrier is a triglyceride; and 
 (d) an organoleptic additive selected from the group consisting of a plasticizer, a buffering agent, a sweetener, a filler, a coloring agent and mixtures of the foregoing and wherein: 
 the chewing gum composition comprises 0% to about 0.5% by weight based upon the total weight of the chewing gum composition of a liquid containing hydroxyl moieties; 
 the chewing gum composition contains no more than 5% of the trans nicotine-N-oxide and no more than 3% of the cis nicotine-N-oxide when placed in a sealed plastic bottle and stored for four (4) weeks at 50° C. and 75% relative humidity; and 
 the chewing gum composition contains no more than 5% of the trans nicotine-N-oxide and no more than 2.5% of the cis nicotine-N-oxide when packaged in a foil backed blister package and stored for six months at 40° C. and 75% relative humidity.